Effectiveness of Narrative Exposure Therapy Among Violence Affected Internally Displaced People with Post-Traumatic Stress Disorder in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Post-traumatic stress disorder (PTSD)
研究概览
简要总结
The study aims to assess the effectiveness of Narrative Exposure Therapy (NET) among violence affected Internally Displaced People (IDP) with post-traumatic stress disorder (PTSD) in India.
The sample for the study will consist of IDP from the state of Manipur, who were displaced due to the conflict that began on May 3rd, 2023. The sample size for the study will be 35 individuals. A snowball and purposive sampling method will be used. The study is a randomized waitlist control trial with baseline, post-intervention and follow-up assessments.
The study will be conducted in two phases, pilot phase and main phase. In the pilot phase, NET will be administered to 4 to 5 participants who meet the inclusion and exclusion criteria. The screening tools and assessment tools will be the same as the main phase of the study. Written feedback will be collected from participants after each session to determine if modifications in delivery, content, activities are required. Findings from this feedback will be incorporated to make any necessary adjustments to the therapy modality for the main phase, if required.
For the main phase of the study, 35 screened participants who consent to participate will be included. Baseline assessments will be carried out for all participants. Following the baseline measures, participants will be randomly assigned to experimental and waitlist control group (20:15). The experimental group will be given the intervention first. Post-intervention assessments will be conducted for both experimental and control groups (control group will not have received any intervention at this point). Preliminary analysis of the control group’s scores will be performed to assess spontaneous remission and to verify whether participants continue to meet the inclusion criteria. In-depth interviews will be conducted with participants whose scores indicate spontaneous remission, to gain insight into the occurrence of spontaneous remission. The intervention will then be administered to participants in the control group who continue to meet the inclusion criteria. Post-intervention assessments for the control group will be conducted similar to those for the experimental group. 1-month follow-up assessments will be conducted for both experimental and control group participants and a 3-month follow-up assessment will be conducted among the experimental group participants, using the same tools as were used for post-intervention assessments.
Data obtained will be analyzed using suitable quantitative and qualitative methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Experience of the event as established by the Exposure to event questionnaire.
- •Able to understand English.
排除标准
- •Individuals currently undergoing other forms of psycho-social therapies by mental health professionals.
- •(Individuals who have been on stable medicines for anxiety or depression for the past four weeks and are likely to not change their prescription during the course of the intervention will be included in the study)
- •Individuals with psychosis and high suicidal risk as assessed by the screening tool.
- •Individuals who are dependent or have high risk of dependence to substance as assessed by the screening tool.
结局指标
主要结局
Post-traumatic stress disorder (PTSD)
时间窗: At baseline, post intervention, at 1 month post intervention, at 3 months post intervention
次要结局
- Depression symptoms(At baseline, post intervention, at 1 month post intervention, at 3 months post intervention)
- Anxiety symptoms(At baseline, post intervention, at 1 month post intervention, at 3 months post intervention)
- Psycho-social functioning(At baseline, post intervention, at 1 month post intervention, at 3 months post intervention)
研究者
Chaitali Mendon
National Institute of Mental Health and Neurosciences
